Laparoscopic Approach to Cervical Cancer
LACC
A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer
1 other identifier
interventional
636
13 countries
33
Brief Summary
The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedApril 18, 2023
April 1, 2023
14.2 years
January 31, 2008
April 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival
Compare treatment equivalence
5 years from surgery
Secondary Outcomes (7)
Patterns of recurrence
5 years from surgery
Costs
6 months from surgery
Quality of life Questionnaires
6 months from surgery
Pelvic Floor Distress Inventory Questionnaire
5 years from surgery
Overall survival
5 years from surgery
- +2 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORTotal Abdominal Radical Hysterectomy
2
EXPERIMENTALTotal Laparoscopic or Robotic Radical Hysterectomy
Interventions
In a radical hysterectomy the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix are excised.
In a radical hysterectomy the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix are excised.
Eligibility Criteria
You may qualify if:
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
- Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, or stage IB1 disease
- Patients undergoing either a Type II or III radical hysterectomy (Piver Classification)
- Patients with adequate bone marrow, renal and hepatic function:
- ECOG Performance Status of 0 or 1.
- Patient must be suitable candidates for surgery.
- Patients who have signed an approved Informed Consent
- Patients with a prior malignancy allowed if \> 5 years ago with no current evidence of disease
- Females, aged 18 years or older
- Negative serum pregnancy test within \<30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause
You may not qualify if:
- Any histology other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
- Tumor size greater than 4 cm;
- FIGO stage II-IV;
- Patients with a history of pelvic or abdominal radiotherapy;
- Patients who are pregnant;
- Patients with contraindications to surgery;
- Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \> 2cm; or histologically positive lymph nodes
- Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- Patient compliance and geographic proximity that do not allow adequate follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Greater Baltimore Medical Centre
Baltimore, Maryland, 21204, United States
Women's Cancer Centre Nevada
Las Vegas, Nevada, 89169, United States
St Luke's - Roosevelt Hospital Center
New York, New York, 10019, United States
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, 73104, United States
M.D. Anderson Cancer Center
Houston, Texas, 77230-1439, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Misericordia Hospital
Córdoba, Argentina
The Wesley Hospital
Auchenflower, Queensland, 4066, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, 4120, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Mater Health Services
South Brisbane, Queensland, 4101, Australia
The Townsville Hospital
Townsville, Queensland, 4814, Australia
Saint John of God
Subiaco, Western Australia, Australia
Erastus Gaertner Hospital
Curitiba, Paraná, Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil
Instituto Brasileiro de Controlle do Cancer
Brás, São Paulo, Brazil
Albert Einstein Hospital
Morumbi, São Paulo, Brazil
University Hospital Pleven Center of Oncology Gynaecology
Pleven, 5800, Bulgaria
Princess Margaret Hospital
Toronto, Ontario, Canada
The First Affilated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000, China
Institito De Cancerologia Clinica Las Americas
Antioquia, Medellin, Colombia
Alessandro Manzoni Hospital
Lecco, Milan, Italy
San Gerardo Hospital
Monza, Milan, Italy
Catholic University of the Sacred Heart
Milan, Rome, Italy
European Institute of Oncology
Milan, 20141, Italy
Instituto Nacional de Cencerologia
Tlalpan, Mexico City, Mexico
Instituto Nacional de Enfermedades Neoplasicas
Lima, Surquillo, Peru
Gyneco-Oncologico Hospital HIMA
Caguas, San Pablo, Puerto Rico
Korea Cancer Hospital
Goyang-si, Seoul, South Korea
Seoul National University - Department of Obstetrics and Gynecology
Ihwa-dong, Seoul, South Korea
ASAN Medical Center
Seoul, South Korea
Related Publications (5)
Obermair A, Gebski V, Frumovitz M, Soliman PT, Schmeler KM, Levenback C, Ramirez PT. A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):584-8. doi: 10.1016/j.jmig.2008.06.013.
PMID: 18722970BACKGROUNDRamirez PT, Robledo KP, Frumovitz M, Pareja R, Ribeiro R, Lopez A, Yan X, Isla D, Moretti R, Bernardini MQ, Gebski V, Asher R, Behan V, Coleman RL, Obermair A. LACC Trial: Final Analysis on Overall Survival Comparing Open Versus Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer. J Clin Oncol. 2024 Aug 10;42(23):2741-2746. doi: 10.1200/JCO.23.02335. Epub 2024 May 29.
PMID: 38810208DERIVEDTanaka T, Ueda S, Miyamoto S, Hashida S, Terada S, Konishi H, Kogata Y, Taniguchi K, Komura K, Ohmichi M. Comparison of Prognosis between Minimally Invasive and Abdominal Radical Hysterectomy for Patients with Early-Stage Cervical Cancer. Curr Oncol. 2022 Mar 24;29(4):2272-2283. doi: 10.3390/curroncol29040185.
PMID: 35448159DERIVEDFrumovitz M, Obermair A, Coleman RL, Pareja R, Lopez A, Ribero R, Isla D, Rendon G, Bernardini MQ, Buda A, Moretti-Marquez R, Zevallos A, Vieira MA, Zhu T, Land RP, Nicklin J, Asher R, Robledo KP, Gebski V, Ramirez PT. Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2020 Jun;21(6):851-860. doi: 10.1016/S1470-2045(20)30081-4.
PMID: 32502445DERIVEDRamirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.
PMID: 30380365DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pedro Ramirez, M.D.
M.D. Anderson Cancer Center
- STUDY CHAIR
Andreas Obermair, MD
Queensland Centre for Gynecological Cancer
- STUDY CHAIR
Michael Frumovitz, M.D.
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 13, 2008
Study Start
January 1, 2008
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share